MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA MAYFIELD SWIVEL ADAPTOR A1018

Catalog Number	A1018
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mayfield swivel adaptor (a1018) was returned for evaluation: device history record (dhr) - the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - the customer's statement is confirmed as valid after evaluating the device.The inspection of the swivel adapter shows that the swivel adapter assembly's small parts must be replaced including the worn nylon washers and worn and loose retaining rings.To resolve all issues, the swivel adapter¿s nylon washers and the retaining rings were replaced, the unit was reassembled, and the functional test was carried out successfully and the device meets manufacturer specifications.Root cause - the complaint is confirmed via inspection of the unit due to the swivel adapter needing replacement of small parts.The probable root cause is routine use and wear of the unit.No further corrective action beyond these repairs is required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
This is 3 of 3 reports linked to mfg report numbers: 3004608878-2026-00010 3004608878-2026-00011.An authorized distributor reported that the mayfield swivel adaptor (a1018) gave way and did not fix during surgery.The incident caused an increase in surgical time of more than 30 minutes, due to the need to manage the situation.There was no death, but rather lacerations to the scalp, constituting an injury associated with the event.The event occurred in (b)(6) hospital.

• Brand Name: MAYFIELD SWIVEL ADAPTOR A1018
• Common Device Name: MAYFIELD
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24329069
• Report Number: 3004608878-2026-00012
• Device Sequence Number: 21201243
• Product Code: FWZ
• UDI-Device Identifier: 10381780267515
• UDI-Public: 10381780267515
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: A1018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAYFIELD SKULL CLAMP (A1059); MAYFIELD ULTRA BASE UNIT (A2101)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown